Ketorolac-BP

Ketorolac

One ml of solution for injection contains ketorolac trometamol 30 mg. Excipients with known effect: ethanol, sodium.

Indication: Short-term treatment of moderate to severe acute pain, especially post-operative pain.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Ketorolac-BP is contraindicated in patients with hypersensitivity to ketorolac or to any of the excipients listed in section 6.1; - hypersensitivity to other non-steroidal anti-inflammatory drugs (NSAIDs) and in patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-type reactions have been observed in such patients). These reactions include asthma, rhinitis, angioedema or urticaria. − patients with a history of bronchial asthma − patients with nasal polyps, angioedema or bronchospasm - Like other NSAIDs, Ketorolac-BP is contraindicated in patients with severe heart failure and hepatic impairment. - patients with moderate to severe renal impairment (serum creatinine > 160 μmol/litre) or patients at risk of renal failure due to volume depletion or dehydration. - patients with active peptic ulcer or a history of gastrointestinal bleeding, ulceration or perforation. - Ketorolac trometamol inhibits platelet function and is therefore contraindicated in patients with suspected or confirmed cerebrovascular haemorrhage, in patients undergoing surgery with a high risk of bleeding or incomplete haemostasis, and in those at high risk of bleeding, e.g. patients with haemorrhagic diathesis, including coagulation disorders. - Ketorolac trometamol is contraindicated as prophylactic preoperative analgesia because of inhibition of platelet aggregation, and is contraindicated intraoperatively because of the increased risk of bleeding. Ketorolac-BP is contraindicated - in patients currently using acetylsalicylic acid or other NSAIDs. - in combination with oxpentifylline (pentoxifylline), lithium salts, probenecid. - in patients receiving oral anticoagulants, including warfarin, and low-dose heparin (2500-5000 IU every 12 hours). Ketorolac-BP is contraindicated in children and adolescents under 16 years of age. Ketorolac-BP is contraindicated during pregnancy, labour, delivery or breast-feeding (see section 4.6). Ketorolac-BP solution for injection is contraindicated for neuraxial administration (epidural or intrathecal) because of its alcohol content.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Gastrointestinal toxicity Elderly: Elderly patients have a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding or perforation, which can be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of gastrointestinal events. Epidemiological data suggest that ketorolac may be associated with a higher risk of severe GI toxicity relative to other NSAIDs, particularly when used without […]